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Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC)

Primary Purpose

Thymoma Malignant Recurrent

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiotherapy
Surveillance after resection
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma Malignant Recurrent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 < Age < 75 years old
  2. ECOG performance status ≤1
  3. Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection.
  4. Histologically diagnosed thymoma at pathological examination of surgical specimen after pathological review; for note, centralized, real-time, systematic pathological review is standard through the RYTHMIC network in France
  5. Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status
  6. Stage IIb or III disease according to the Masaoka-Koga staging system; this corresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8th TNM staging system TNM UICC/AJCC
  7. Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) performed before treatment
  8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast showing absence of residual disease after surgical resection of the tumor
  9. Pulmonary function tests after surgery with FEV1 > 1L or ≥ 35% of the theoretical value and DLCO ≥ 40%
  10. Signature of informed consent form

Exclusion Criteria:

- 1. Age > 75 years old 2. Histology of thymic carcinoma 3. Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy 4. Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection) 5. Uncontrolled, clinically significant pleural or pericardial effusion 6. Patients with prior radiation therapy to the thorax. Patients treated with conformal radiotherapy for prior breast or head and neck neoplasms should be discussed with PI 7. Evidence of severe or uncontrolled systemic disease as judged by the investigator 8. Recent (< 6 months) severe cardiac disease (uncontrolled arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease. Controlled and non clinically symptomatic arrhythmia is allowed.

9. Current or past history of neoplasm diagnosed within the last 3 years, except: basal cell carcinoma of the skin, in situ carcinoma of the cervix, and bladder in situ. A patient diagnosed for another neoplasm 3 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected 10. Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls, 12. Patients deprived of freedom or under guardianship

Sites / Locations

  • CHU CaenRecruiting
  • CLCC François BACLESSERecruiting
  • CLCC Georges François LeclercRecruiting
  • Centre Oscar LambretRecruiting
  • CHU Lyon
  • AP-HM Hôpital NordRecruiting
  • Institut du Cancer de Montpellier
  • Institut CurieRecruiting
  • Hôpital Bichat AP-HP
  • CHU Rennes Hôpital Sud
  • CHU Rouen
  • CLCC Henri Becquerel
  • Institut de Cancérologie de l'OuestRecruiting
  • CHU Strasbourg
  • Institut Claudius RegaudRecruiting
  • CHRU Tours
  • Institut de Cancérologie de Lorraine Nancy
  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Post-operative radiotherapy

Surveillance after tumour resection

Arm Description

Tumour resection followed by radiotherapy.

Tumour resection

Outcomes

Primary Outcome Measures

Recurrence-Free survival (RFS)
to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Secondary Outcome Measures

Local-regional (pleural or pericardial) recurrence
Local-regional (pleural or pericardial) recurrence; location of recurrence /removed

Full Information

First Posted
January 26, 2021
Last Updated
June 2, 2023
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT04731610
Brief Title
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
Acronym
RADIO-RYTHMIC
Official Title
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
March 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma Malignant Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-operative radiotherapy
Arm Type
Other
Arm Description
Tumour resection followed by radiotherapy.
Arm Title
Surveillance after tumour resection
Arm Type
Other
Arm Description
Tumour resection
Intervention Type
Other
Intervention Name(s)
Radiotherapy
Intervention Description
postoperative radiotherapy after complete resection of thymoma
Intervention Type
Other
Intervention Name(s)
Surveillance after resection
Intervention Description
Surveillance after tumour resection
Primary Outcome Measure Information:
Title
Recurrence-Free survival (RFS)
Description
to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Local-regional (pleural or pericardial) recurrence
Description
Local-regional (pleural or pericardial) recurrence; location of recurrence /removed
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 < Age < 75 years old ECOG performance status ≤1 Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection. Histologically diagnosed thymoma at pathological examination of surgical specimen after pathological review; for note, centralized, real-time, systematic pathological review is standard through the RYTHMIC network in France Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status Stage IIb or III disease according to the Masaoka-Koga staging system; this corresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8th TNM staging system TNM UICC/AJCC Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) performed before treatment Availability of a thoracic Computed-Tomography (CT) scan with IV contrast showing absence of residual disease after surgical resection of the tumor Pulmonary function tests after surgery with FEV1 > 1L or ≥ 35% of the theoretical value and DLCO ≥ 40% Signature of informed consent form Exclusion Criteria: - 1. Age > 75 years old 2. Histology of thymic carcinoma 3. Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy 4. Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection) 5. Uncontrolled, clinically significant pleural or pericardial effusion 6. Patients with prior radiation therapy to the thorax. Patients treated with conformal radiotherapy for prior breast or head and neck neoplasms should be discussed with PI 7. Evidence of severe or uncontrolled systemic disease as judged by the investigator 8. Recent (< 6 months) severe cardiac disease (uncontrolled arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease. Controlled and non clinically symptomatic arrhythmia is allowed. 9. Current or past history of neoplasm diagnosed within the last 3 years, except: basal cell carcinoma of the skin, in situ carcinoma of the cervix, and bladder in situ. A patient diagnosed for another neoplasm 3 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected 10. Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls, 12. Patients deprived of freedom or under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis NYASSE
Phone
(0) 1.47.11.18. 91
Ext
33
Email
gilles.nyassemessene@curie.fr
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon DESHAYES, MD
First Name & Middle Initial & Last Name & Degree
Simon DESHAYES, MD
Facility Name
CLCC François BACLESSE
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine LEROUGE, MD
First Name & Middle Initial & Last Name & Degree
Delphine LEROUGE, MD
Facility Name
CLCC Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne MARTIN, MD
First Name & Middle Initial & Last Name & Degree
Etienne MARTIN, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence LE TINIER, MD
First Name & Middle Initial & Last Name & Degree
Florence LE TINIER, MD
Facility Name
CHU Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas PIERRET, MD
First Name & Middle Initial & Last Name & Degree
Thomas PIERRET, MD
Facility Name
AP-HM Hôpital Nord
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal THOMAS, Pr
First Name & Middle Initial & Last Name & Degree
Pascal THOMAS, Pr
Facility Name
Institut du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier QUANTIN, Pr
First Name & Middle Initial & Last Name & Degree
Xavier QUANTIN, Pr
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRARD, PR
Email
nicolas.girard2@curie.fr
First Name & Middle Initial & Last Name & Degree
Nicolas GIRARD, PR
Facility Name
Hôpital Bichat AP-HP
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MORDANT, Pr
First Name & Middle Initial & Last Name & Degree
Pierre MORDANT, Pr
Facility Name
CHU Rennes Hôpital Sud
City
Rennes
ZIP/Postal Code
35056
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles RICORDEL, MD
First Name & Middle Initial & Last Name & Degree
Charles RICORDEL, MD
Facility Name
CHU Rouen
City
Rouen
Country
France
Individual Site Status
Withdrawn
Facility Name
CLCC Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien THUREAU, MD
First Name & Middle Initial & Last Name & Degree
Sébastien THUREAU, MD
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François THILLAYS, MD
First Name & Middle Initial & Last Name & Degree
François THILLAYS, Pr
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel FALCOZ, Pr
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel FALCOZ, Pr
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan KHALIFA, MD
First Name & Middle Initial & Last Name & Degree
Jonathan KHALIFA, MD
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric PICHON, MD
First Name & Middle Initial & Last Name & Degree
Eric PICHON, MD
Facility Name
Institut de Cancérologie de Lorraine Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde CUENIN, MD
First Name & Middle Initial & Last Name & Degree
Mathilde CUENIN, MD
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela BOTTICELLA, MD
First Name & Middle Initial & Last Name & Degree
Angela BOTTICELLA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

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